Compounded Preparation Beyond-Use Date
Beyond-use date of a compounded preparation.
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Example
- Sterile or nonsterile
- Sterile (USP <797>)
- Compounded
- 2026-10-05T09:30
- Sterile: <797> category
- Category 2
- Sterile: method
- Aseptically processed
- Sterile: passed sterility testing
- No
- Sterile: any nonsterile starting component
- No
- Sterile: storage
- Refrigerator
Result: Beyond-use: October 15, 2026, 9:30 am, set by the USP limit of 10 days (Category 2, aseptically processed, not sterility tested, sterile components only, refrigerated), counted from compounding at October 5, 2026, 9:30 am.
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What you enter
- Sterile or nonsterile
- Compounded (YYYY-MM-DDTHH:MM)
- Sterile: <797> category
- Sterile: method
- Sterile: passed sterility testing
- Sterile: any nonsterile starting component
- Sterile: storage
- Nonsterile: dosage form and water activity
- Earliest component expiration (YYYY-MM-DD)
How this is calculated
Citation
USP, Compounding Standards and Beyond-Use Dates fact sheet: the revised <797> Category 1, 2 and 3 limits by method, sterility testing, starting components and storage, and the revised <795> limits by water activity; the BUD may not pass the earliest component expiration. Read the source ↗
A reference and educational tool. Not medical, legal, or financial advice, and not a substitute for clinician judgment.